Synthetic nicotine, an FDA loophole

Because it is not derived from tobacco, synthetic nicotine is outside the control of the Food and Drug Administration (FDA) and can still be sold in the United States in many flavors, creating a gap between tobacco and nicotine products.

Although the FDA initiated a review of all vaping products in July 2020, most of which have since been banned, an entire segment of this sector remains unregulated. Although it has been authorized since 2009 to oversee everything related to tobacco and nicotine products, the synthetic nicotine segment would fall outside its remit, on the grounds that it is not a direct derivative of tobacco.

A commercially profitable legal uncertainty

This legal loophole has already been exploited since 2021, particularly by the Puff Bar brand. After being ordered by the FDA in 2020 to withdraw its disposable e-cigarettes and numerous flavored e-liquids from the market, the brand once again marketed disposable e-cigarettes containing synthetic nicotine in February 2021.[1]This subterfuge allows it, in particular, to continue selling flavored products that are popular with young people. A study carried out in early 2021 for the Centers for Disease Control and Prevention (CDC) and the FDA indicates that nearly 85% of middle school students who use e-cigarettes opt for flavored flavors, with fruit, dessert, candy, or mint/menthol flavors being the most popular.[2]The study also specifies that among e-cigarette users, 53% already use disposable models, placing Puff Bar in first position among the brands cited (26% among high school students, 30% among middle school students).

“Adults like aromas”, defended Patrick Beltran, co-founder and general manager of Puff Bar. "The fact that we have flavors does not necessarily mean that we are targeting young people.", he added, blaming the sale to minors on traders and the inventiveness of minors, as in the case of alcohol sales.[3]. In an argument very similar to that of the cigarette manufacturers, he also invited the FDA to look more closely at the issue of counterfeit synthetic vape products.

FDA weakened by turnover of its leaders

A Republican senator, Mikie Sherill, did attempt to include synthetic nicotine within the FDA's purview, but the motion did not receive sufficient support. The FDA itself has warned that it intends to take up this issue and that it will address issues "on a case-by-case basis" until then. This seems hypothetical for now: Robert Califf, Joe Biden's nominee to take over the FDA, may not garner all the necessary votes. Furthermore, Mitch Zeller, head of the FDA's tobacco branch, is due to leave his post next April. These two uncertainties risk delaying decisions on tobacco and nicotine even further.

Available since 2014, synthetic nicotine was still an expensive product a few years ago, and few people believed in its commercial potential, with most tobacco and vaping product manufacturers having turned away from it. Although it remains more expensive than nicotine from tobacco, synthetic nicotine has now become significantly more affordable and is attracting interest from manufacturers. New entrants to this market, such as Zanoprima, are also expected to reshuffle the cards and be tempted to exploit this legal loophole.[4]A path that other manufacturers could in turn take, and which calls for a rapid decision on synthetic nicotine-based products.

Keywords: synthetic nicotine, flavors, youth, FDA, Puff Bar, United States

©Generation Without Tobacco

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[1] United States: new circumvention of the ban on the sale of flavored vaping products, Generation Without Tobacco, published March 5, 2021, accessed February 8, 2022. [2] Youth E-Cigarette Use Remains Serious Public Health Concern Amid COVID-19 Pandemic, Centers for Disease Control and Prevention, published September 30, 2021, accessed February 8, 2022. [3] Foley KE, Synthetic nicotine: Unregulated and increasingly popular, Politico, published February 7, 2022, accessed February 8, 2022. [4] A laboratory markets a new synthetic nicotine, Generation Without Tobacco, published October 15, 2021, accessed February 8, 2022. National Committee Against Smoking |